Autism Spectrum DisorderNCT06790199
Implementation of a Teacher Classroom Program to Support Preschool Children With Autism or Developmental Problems
A study testing Incredible Years® "Helping Preschool Children with Autism" program (IY-HPCA) in people with Autism Spectrum Disorder and Teacher Training, run by Fundació Sant Joan de Déu at 1 site in Spain.
Trial summary
The Incredible Years® "Helping Preschool Children with Autism" (IY-HPCA) program is designed for teachers of children aged 2 to 5 years who have students with autism in their classrooms. The program provides tools to support children with autism. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Teacher Training, Teacher Skills in Addressing Child Mental Health Problem
- What is being tested?
- Incredible Years® "Helping Preschool Children with Autism" program (IY-HPCA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 25 Nov 2024to 26 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Teachers working at mainstream schools near the catchment area of Hospital Sant Joan de Déu Barcelona.
- Teachers working at mainstream schools with specific programs for children with special needs.
- Teachers of pre-school children.
- Teachers willing to participate in the study and signing the inform consent.
Who cannot join
- Teachers working at special education centers instead of mainstream schools.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mixed-methods Evaluation of the Implementation of a Teacher Classroom Program to Support Preschool Children With Autism or Developmental Problems: A Feasibility Randomized Controlled Pilot Trial
The Incredible Years® "Helping Preschool Children with Autism" (IY-HPCA) program is designed for teachers of children aged 2 to 5 years who have students with autism in their classrooms. The program provides tools to support children with autism.
The primary aim of this pilot study is to examine the feasibility of implementing the IY-HPCA intervention among teachers of preschool children (typically aged 2 to 5 years) working in mainstream schools. Specifically, the study aims to assess teachers' engagement, acceptability, and satisfaction with the program. Secondarily, it aims to gather preliminary evidence on the program's effectiveness in improving teachers' use of strategies, teacher self-efficacy, and in reducing burnout.
Read more
An exploratory randomized controlled pilot trial will be conducted. Approximately 40 teachers will be recruited, and they will be randomly assigned to either an intervention or control group.
The intervention consists of six weekly sessions lasting 3 hours each, delivered by clinical psychologists and child psychiatrists specialized in developmental disorders at Hospital Sant Joan de Déu, in Barcelona. Two intervention face-to-face groups will be conducted at Hospital Sant Joan de Déu.
Feasibility outcomes include program attendance, acceptability, and satisfaction (assessed using the Incredible Years Teacher Workshop Evaluations and the Teacher Satisfaction Questionnaire), as well as fidelity to the intervention delivery (measured with the Leader Checklist). After the intervention, individual interviews with teachers and group leaders will qualitatively assess satisfaction and experiences with the program.
Secondary (effectiveness) outcomes include teachers' use of strategies (Teacher Strategies Questionnaire for Children with Autism), self-efficacy (Teacher Sense of Efficacy Scale), and burnout (Maslach Burnout Inventory-Educators Survey).
This study will provide pioneering insights into the implementation of this program within the public mental health and education systems in Spain. This will allow the potential implementation of a wider randomized controlled trial in the future at a larger scale.
- Conditions
- Autism Spectrum Disorder, Teacher Training, Teacher Skills in Addressing Child Mental Health Problem, Developmental Disorders
- Being tested
- Incredible Years® "Helping Preschool Children with Autism" program (IY-HPCA)
- Keywords
- Autism, Teacher training, Developmental disorders, Randomized controlled trial, Early intervention, Mental health
- Medical subject headings
- Autism Spectrum Disorder, Developmental Disabilities, Autistic Disorder, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incredible Years® "Helping Preschool Children with Autism" program (IY-HPCA)Behavioural
The IY-HPCA® program is a face-to-face 6-session group-based intervention for preschool teachers of children aged 2-5 with ASD or language and communication difficulties. Sessions last 3 hours, are delivered weekly, and are led by two trained co-leaders who have experience working with children on the autism spectrum. The program covers three main topics: (1) language development, (2) social interactions, and (3) emotion literacy and self-regulation. Teachers learn about coaching language, imitation, sensory routines, social communication, use of pretend and puppet play, and self-regulation skills. Visual supports such as picture schedules, choice cards, command and feelings cards are used, and practices are tailored to children's communication and play level stages. The intervention is structured and includes role-playing techniques and video visualization.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (Incredible Years-Helping Preschool Children with Autism program) | Experimental | Teachers in the intervention group will receive the Incredible Years-Helping Preschool Children with Autism program (IY-HPCA).
They will participate in a 6-session group-based face-to-face intervention. Sessions will last 3 hours, will be delivered weekly at Hospital Sant Joan de Déu, and will be led by two trained co-leaders. The following main topics will be covered: (1) language development, (2) social interactions, and (3) emotion literacy and self-regulation.
Two groups will be conducted, and each of them will include around 10 teachers. Receives: Behavioral: Incredible Years® "Helping Preschool Children with Autism" program (IY-HPCA) |
| Control group | No intervention | The control group will not receive the intervention. Teachers who are assigned to the control group will continue their usual teaching practice. No restrictions will be placed on schools regarding access to other training and support services during the course of the study, but this information will be monitored as a potential confounder. Teachers who are assigned to the intervention group will be asked not to share the intervention contents with other teachers who are in the control group before the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of teachers engaging with and finishing the program
Teachers' attendance at the sessions will be regeristered weekly with a sheet of attendance, with the aim to determine levels of compliance and engagement with the intervention. An attendance of at least 4/6 sessions is expected, with a minimum of 50% of teachers finishing the program.
Measured: Attendance sheet completed weekly throughout the intervention (6 weeks total)
Compliance and satisfaction throughout the study (Incredible Years Teacher Weekly Evaluations)
Teachers' compliance and satisfaction with the intervention will be assessed weekly after each session with the questionnaire "Incredible Years Teacher Weekly Evaluations", which is part of the IY-HPCA® program materials.
This weekly assessment asks teachers to rate their satisfaction with different aspects of the program.
Measured: Questionnaire administered to the intervention group weekly throughout the intervention (6 weeks total)
Teachers' acceptability and satisfaction with the program (evaluated with the Final Participant Satisfaction Questionnaire)
Teachers' acceptability and satisfaction with the program will be assessed with the Final Participant Satisfaction Questionnaire-Helping Preschool Children with Autism Program (included within the IY-HPCA® program). Data will be collected after the last session of the intervention.
Measured: Administered to the intervention group at intervention completion (approximately 6 weeks after baseline)
Teachers' overall experiences with the program (evaluated with individual interviews)
Individual interviews will be conducted after the last session of the intervention to explore from a qualitative perspective: (1) teachers' acceptability, satisfaction and overall experience and perceptions of the intervention, and (2) teachers' perceived changes in their skills after the intervention.
Outcome measurements 3 and 4 will be combined to determine teachers' experiences, acceptability and satisfaction with the program.
Measured: Interviews to the participants of the intervention group at intervention completion (approximately 6 weeks after baseline)
Group leaders' fidelity with the program (evaluated with the Leader Checklist)
Fidelity with the program will be assessed weekly after each session with the "Leader Checklist", which is part of the IY-HPCA® program materials. Group leaders (clinicians) will complete the Leader Checklist.
Measured: Leader Checklist completed weekly throughout the intervention (6 weeks total)
Clinicians' experiences with the intervention delivered (evaluated with individual interviews)
Individual interviews will be conducted after the last session with clinicians who delivered the intervention.
Measured: Interviews to clinicians at intervention completion (approximately 6 weeks after baseline)
Secondary outcomes (3)
Changes from baseline to post-intervention in Teacher Strategies Questionnaire for Children with Autism (TSQ-A)
The Teacher Strategies Questionnaire for Children with Autism (TSQ-A) is a 52-item teacher-report questionnaire part of the IY program materials that consists of six sections. The first section asks teachers to rate their confidence in promoting social, emotional, language and academic development of children with ASD. Sections 2-4 ask teachers to rate the frequency with which they use teaching techniques to support children's language, social and emotional development. In the last section, teachers rate the frequency of their planning and support strategies according to a five-point scale.
Measured: Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)
Changes from baseline to post-intervention in Teacher Sense of Efficacy Scale-Long Version
The Teacher Sense of Efficacy Scale-Long Version (Tschannen-Moran \& Hoy, 2001; Spanish version: Salas-Rodríguez et al., 2021) is a 24-item questionnaire that measures teachers' evaluations of how likely they are to be successful in teaching. Three different subscales are differentiated: efficacy for classroom management, efficacy to promote student engagement, and efficacy in using instructional strategies.
Measured: Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)
Changes from baseline to post-intervention in Maslach Burnout Inventory-Educators Survey
The Maslach Burnout Inventory-Educators Survey (Maslach et al., 1986) is a version of the original Maslach Burnout Inventory for use with educators, including teachers, and has three scales that examine the three core aspects of burnout: emotional exhaustion (feelings of being emotionally overextended and exhausted by one's work), depersonalization (unfeeling and impersonal response toward recipients of one's instruction) and personal accomplishment (feelings of competence and successful achievement in one's work with students).
Measured: Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start25 Nov 2024
- Primary completion26 Jan 2026
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Sant Joan de Déu
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790199
- Sponsor's protocol ID
- PIC-179-24
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hayes R, Titheradge D, Allen K, Allwood M, Byford S, Edwards V, Hansford L, Longdon B, Norman S, Norwich B, Russell AE, Price A, Ukoumunne OC, Ford T. The Incredible Years(R) Teacher Classroom Management programme and its impact on teachers' professional self-efficacy, work-related stress, and general well-being: Results from the STARS randomized controlled trial. Br J Educ Psychol. 2020 May;90(2):330-348. doi: 10.1111/bjep.12284. Epub 2019 Apr 13.
PubMed 30980389Serrano M, Elias M, Llorens M, Bolasell M, Vall-Roque H, Villalta L. Early treatment for children with mental health problems and genetic conditions through a parenting intervention (The GAP): study protocol for a pragmatic randomized controlled trial. Trials. 2024 Jul 20;25(1):496. doi: 10.1186/s13063-024-08278-4.
PubMed 39033111
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-methods Evaluation of the Implementation of a Teacher Classroom Program to Support Preschool Children With Autism or Developmental Problems: A Feasibility Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT06790199
- Acronym / sponsor ID
- PIC-179-24
- Conditions
- Autism Spectrum Disorder, Teacher Training, Teacher Skills in Addressing Child Mental Health Problem, Developmental Disorders
- Keywords
- Autism, Teacher training, Developmental disorders, Randomized controlled trial, Early intervention, Mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Fundació Sant Joan de DéuUniversity, hospital or other
- Collaborators
- Fundació La Marató de TV3
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 26 Jan 2026 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Incredible Years® "Helping Preschool Children with Autism" (IY-HPCA) program is designed for teachers of children aged 2 to 5 years who have students with autism in their classrooms. The program provides tools to support children with autism.
The primary aim of this pilot study is to examine the feasibility of implementing the IY-HPCA intervention among teachers of preschool children (typically aged 2 to 5 years) working in mainstream schools. Specifically, the study aims to assess teachers' engagement, acceptability, and satisfaction with the program. Secondarily, it aims to gather preliminary evidence on the program's effectiveness in improving teachers' use of strategies, teacher self-efficacy, and in reducing burnout.
An exploratory randomized controlled pilot trial will be conducted. Approximately 40 teachers will be recruited, and they will be randomly assigned to either an intervention or control group.
The intervention consists of six weekly sessions lasting 3 hours each, delivered by clinical psychologists and child psychiatrists specialized in developmental disorders at Hospital Sant Joan de Déu, in Barcelona. Two intervention face-to-face groups will be conducted at Hospital Sant Joan de Déu.
Feasibility outcomes include program attendance, acceptability, and satisfaction (assessed using the Incredible Years Teacher Workshop Evaluations and the Teacher Satisfaction Questionnaire), as well as fidelity to the intervention delivery (measured with the Leader Checklist). After the intervention, individual interviews with teachers and group leaders will qualitatively assess satisfaction and experiences with the program.
Secondary (effectiveness) outcomes include teachers' use of strategies (Teacher Strategies Questionnaire for Children with Autism), self-efficacy (Teacher Sense of Efficacy Scale), and burnout (Maslach Burnout Inventory-Educators Survey).
This study will provide pioneering insights into the implementation of this program within the public mental health and education systems in Spain. This will allow the potential implementation of a wider randomized controlled trial in the future at a larger scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (Incredible Years-Helping Preschool Children with Autism program) | Experimental | Behavioral: Incredible Years® "Helping Preschool Children with Autism" program (IY-HPCA)Teachers in the intervention group will receive the Incredible Years-Helping Preschool Children with Autism program (IY-HPCA). They will participate in a 6-session group-based face-to-face intervention. Sessions will last 3 hours, will be delivered weekly at Hospital Sant Joan de Déu, and will be led by two trained co-leaders. The following main topics will be covered: (1) language development, (2) social interactions, and (3) emotion literacy and self-regulation. Two groups will be conducted, and each of them will include around 10 teachers. |
| Control group | No intervention | –The control group will not receive the intervention. Teachers who are assigned to the control group will continue their usual teaching practice. No restrictions will be placed on schools regarding access to other training and support services during the course of the study, but this information will be monitored as a potential confounder. Teachers who are assigned to the intervention group will be asked not to share the intervention contents with other teachers who are in the control group before the end of the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Teachers working at mainstream schools near the catchment area of Hospital Sant Joan de Déu Barcelona.
- Teachers working at mainstream schools with specific programs for children with special needs.
- Teachers of pre-school children.
- Teachers willing to participate in the study and signing the inform consent.
Key exclusion criteria (1 listed)
- Teachers working at special education centers instead of mainstream schools.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incredible Years® "Helping Preschool Children with Autism" program (IY-HPCA)The IY-HPCA® program is a face-to-face 6-session group-based intervention for preschool teachers of children aged 2-5 with ASD or language and communication difficulties. Sessions last 3 hours, are delivered weekly, and are led by two trained co-leaders who have experience working with children on the autism spectrum. The program covers three main topics: (1) language development, (2) social interactions, and (3) emotion literacy and self-regulation. Teachers learn about coaching language, imitation, sensory routines, social communication, use of pretend and puppet play, and self-regulation skills. Visual supports such as picture schedules, choice cards, command and feelings cards are used, and practices are tailored to children's communication and play level stages. The intervention is structured and includes role-playing techniques and video visualization. | Behavioural | Intervention group (Incredible Years-Helping Preschool Children with Autism program) |
Primary outcome
Percentage of teachers engaging with and finishing the program
Time frame: Attendance sheet completed weekly throughout the intervention (6 weeks total)
Teachers' attendance at the sessions will be regeristered weekly with a sheet of attendance, with the aim to determine levels of compliance and engagement with the intervention. An attendance of at least 4/6 sessions is expected, with a minimum of 50% of teachers finishing the program.
Compliance and satisfaction throughout the study (Incredible Years Teacher Weekly Evaluations)
Time frame: Questionnaire administered to the intervention group weekly throughout the intervention (6 weeks total)
Teachers' compliance and satisfaction with the intervention will be assessed weekly after each session with the questionnaire "Incredible Years Teacher Weekly Evaluations", which is part of the IY-HPCA® program materials. This weekly assessment asks teachers to rate their satisfaction with different aspects of the program.
Teachers' acceptability and satisfaction with the program (evaluated with the Final Participant Satisfaction Questionnaire)
Time frame: Administered to the intervention group at intervention completion (approximately 6 weeks after baseline)
Teachers' acceptability and satisfaction with the program will be assessed with the Final Participant Satisfaction Questionnaire-Helping Preschool Children with Autism Program (included within the IY-HPCA® program). Data will be collected after the last session of the intervention.
Teachers' overall experiences with the program (evaluated with individual interviews)
Time frame: Interviews to the participants of the intervention group at intervention completion (approximately 6 weeks after baseline)
Individual interviews will be conducted after the last session of the intervention to explore from a qualitative perspective: (1) teachers' acceptability, satisfaction and overall experience and perceptions of the intervention, and (2) teachers' perceived changes in their skills after the intervention. Outcome measurements 3 and 4 will be combined to determine teachers' experiences, acceptability and satisfaction with the program.
Group leaders' fidelity with the program (evaluated with the Leader Checklist)
Time frame: Leader Checklist completed weekly throughout the intervention (6 weeks total)
Fidelity with the program will be assessed weekly after each session with the "Leader Checklist", which is part of the IY-HPCA® program materials. Group leaders (clinicians) will complete the Leader Checklist.
Clinicians' experiences with the intervention delivered (evaluated with individual interviews)
Time frame: Interviews to clinicians at intervention completion (approximately 6 weeks after baseline)
Individual interviews will be conducted after the last session with clinicians who delivered the intervention.
3 secondary outcomes
Changes from baseline to post-intervention in Teacher Strategies Questionnaire for Children with Autism (TSQ-A)
Time frame: Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)
Changes from baseline to post-intervention in Teacher Sense of Efficacy Scale-Long Version
Time frame: Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)
Changes from baseline to post-intervention in Maslach Burnout Inventory-Educators Survey
Time frame: Administered to the intervention and control group at baseline (prior to programme initiation) and after the intervention (approximately 6 weeks after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 30980389Hayes R, Titheradge D, Allen K, Allwood M, Byford S, Edwards V, Hansford L, Longdon B, Norman S, Norwich B, Russell AE, Price A, Ukoumunne OC, Ford T. The Incredible Years(R) Teacher Classroom Management programme and its impact on teachers' professional self-efficacy, work-related stress, and general well-being: Results from the STARS randomized controlled trial. Br J Educ Psychol. 2020 May;90(2):330-348. doi: 10.1111/bjep.12284. Epub 2019 Apr 13.
- Background: PubMed 39033111Serrano M, Elias M, Llorens M, Bolasell M, Vall-Roque H, Villalta L. Early treatment for children with mental health problems and genetic conditions through a parenting intervention (The GAP): study protocol for a pragmatic randomized controlled trial. Trials. 2024 Jul 20;25(1):496. doi: 10.1186/s13063-024-08278-4.
- Information on The Incredible Years teacher programsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Incredible Years® "Helping Preschool Children with Autism" program (IY-HPCA) in people with Autism Spectrum Disorder and Teacher Training, run by Fundació Sant Joan de Déu at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of teachers engaging with and finishing the program (time frame: Attendance sheet completed weekly throughout the intervention (6 weeks total)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06790199, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.